Understand the criteria for selecting and implementing POCTs

Questions & Answers

Below is the question that was not answered during the Online Meeting.

1. Is it mandatory to enter and release all POCT test results in the system, or could the laboratory simply archive the complete raw data and release it in the laboratory information system upon request (from the physician or patient)?

Yes, all laboratory test results must be linked to a report as stipulated in PALC 2025 Standard, Item 10.11, and RDC 786/2023, Section IV, Post-Analytical Phase, which also outlines the issuance of the report and its criteria for release.

Raw data is also a requirement and must be retained for a minimum period of 5 years, in accordance with RDC 786/2023, Article 81, and PALC 2025 Standard, Item 10.4 (K).

2. In occupational medicine within a hospital unit, where is the COVID-19 test performed?

Each institution can define its own workflow for sample collection and test execution. Typically, tests requested by occupational medicine are collected through outpatient services and performed in the laboratory. If the option is to perform the COVID-19 rapid test within occupational medicine, this process is considered a POCT and must be linked to the clinical laboratory.

3. Are there specific protocols for the validation of POCT, or is the protocol established in the laboratory for other equipment followed? If so, is there any suggested reference?

The validation of POCT tests must adhere to the requirements and criteria adopted by the specialty to which the test is linked (e.g., Hematology, Biochemistry…). These specialties, in turn, must support validation by ensuring, when applicable, tests for linearity, accuracy, reproducibility, and precision. Validation references are specific to each area and may be adapted according to the service or the particularities of each test. It is crucial that the validation generates sufficient statistical data to ensure the safety and reliability of the data and the results analyzed.

4. How could equivalence be established between multiple POCT devices (in our case, blood gas analyzers located in various areas of our Hospital Complex), given that blood samples lack the stability required for use?

This is a significant challenge, as some blood gas parameters have low stability and can undergo changes when the sample is exposed to air. Depending on the characteristics of your equipment, if it is portable, it can be moved and gathered in a single location so that the sample can be processed sequentially, following best practices to minimize exposure of the sample to air. The PALC 2025 standard, requirement 11.9, outlines the need for this verification.

Another alternative is to use the results obtained from proficiency testing to verify if there is harmonization between the devices. It is important to note that the data can only be used for harmonization after receiving the provider’s results. This is possible because RDC 786/2023, Article 151, mandates the inclusion of proficiency testing for 100% of the devices.